Vistafix one-stage surgery quick guide for auricular ... - Cochlear

Cochlear Vistafix ® System *
Vistafix one-stage surgery quick guide for auricular procedures
For detailed instructions, please see the Cochlear Vistafix Treatment and Surgery Guide.
STEP 1 Prepare the site
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• Carefully mark the implant sites. The implants should be located
directly under the anti-helix of the prosthesis.
• Two implants are often sufficient for satisfactory retention,
though three may be needed for optimal retention. The ideal
position is approximately 20 mm from the center of the external
ear canal opening, at 4 o’clock and 1:30 (left side of the patient
— 8:00 and 10:30 on right).
• The distance between the implants should be at least 10 mm.
STEP 2 Make the incision
• Make an incision approximately 10 mm behind the implant
sites, down to the periosteum.
• Make a cruciate incision in the periosteum at the implant site.
• Raise the edges with skin hooks.
STEP 3 Reduce subcutaneous tissue
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Step 4-6 are generally done in one sequence, for one implant at a time. Start with the inferior implant.
STEP 4 Drill with the guide drill
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• Begin drilling with the guide drill and 3 mm spacer (2000 rpm)
using a continuous manual irrigation drip.
• Move the burr up and down and slightly enlarge the hole to ensure
visual inspection, and that the coolant reaches the tip of the drill.
• Check the bottom of the implant site repeatedly for bone.
• Use the drill indicator and abundant irrigation during
all drilling procedures.
• If there is adequate bone thickness, remove the spacer and
continue drilling to 4 mm.
STEP 5 Drill with the widening drill
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• Scrape hair from the flap.
• Remove all subcutaneous tissue with hair follicles under
the skin flap.
• Remove subcutaneous tissue at the periphery of the flap
holding the blade parallel to the skin.
• Trim the soft tissue down to the innermost layer (periosteum)
to avoid regrowth of tissue and to avoid mobility.
• Widen the implant site with the appropriate widening drill/
countersink for the implants being placed (2000 rpm).
• Move the widening drill up and down during drilling to ensure that
the coolant reaches the tip of the drill. Only use up and down
movements, do not make the hole larger than the actual drill size. If
necessary, use the dissector to remove bone chips from the drill flutes.
• When reaching the bone surface, use the widening drill to create a
small countersink in the bone (maximum 0.5 mm). The widening drill
for the Vistafix 3 System has been designed to facilitate countersinking.
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*The Vistafix 3 System consists of: Cochlear Vistafix VXI300 Implant (Vistafix 3 Implant) Cochlear Vistafix VXA300 Abutment (Vistafix 3 Abutment)
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STEP 6 Place the implant
• Pick up the implant with the implant inserter. If using the prior
generation Vistafix Implant, use the connection to handpiece
to pick up the implant.
• Place the implant in the bone without irrigation until two
complete rotations are achieved in the bone. Once two
complete rotations of the implant have occurred, continue
implant placement with drip irrigation.
STEP 7 Close and suture
• Suture the edges around the flap down to the periosteum
in order to hold the tissue in place.
• Lay the flap back and suture it down.
STEP 8 Connect healing abutments or abutments
Healing abutments are recommended for use for all cases at
the initial surgery to facilitate proper healing, with permanent
abutments placed at a later date at the clinic.
• Using a 4 mm biopsy punch, make incisions through the skin
over the implants.
• Pick up the healing abutment or abutment with the abutment
holder and place it into the implant.
• Hand-tighten the screw partially with the abutment holder.
• Snap the abutment holder off the abutment.
• Finalize the tightening of the abutment screw to 25 Ncm
with the machine screwdriver abutment and the counter
torque wrench (low speed setting).
• In case of manual tightening, tighten the abutment screw
to 25 Ncm using the multi wrench (“IN” facing upwards)
with the machine screwdriver abutment. Use the counter
torque wrench to counter torque for Vistafix 3, or the
abutment clamp for prior generation Vistafix.
STEP 9 Place the dressing and healing caps
• Healing abutments — Place a dressing around the healing
abutments. Place a mastoid dressing.
• Abutments — Place the healing cap on the abutment
and hand-tighten the screw using the Unigrip screwdriver.
Place the healing cap either before or after the dressing.
Place a mastoid dressing.
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VFX003 ISS1 JUN12
BONE QUALITY SUGGESTED TORQUE
Compact bone 40-50 Ncm
Compromised or soft bone 20-30 Ncm
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25 Ncm
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25 Ncm